1 Presentation Title Helping Practices Achieve Success through Shared Knowledge
2 Featured Panelists Michele Madison, Partner at Morris, Manning, and Martin, LLP Ms. Madison is highly experienced with the HITECH rules and has been helping clients navigate healthcare laws for nearly 14 years. She will discuss legislative changes affecting Business Associates and how it affects the Covered Entities. Dr. Paige Joyner, CEO at Compliance +, LLC Dr. Paige Joyner is a known expert on HIPAA Privacy & Security regulations. She walk you through what is required in a Privacy & Security Manual. Deborah Frazier Healthcare IT Support Manager at BlueWave Computing Deborah Frazier developed the Healthcare Compliance Program at BlueWave Computing. As a Business Associate, she will discuss the steps on how ensure your Business Associates are meeting the requirements and how to identify if they are a threat to your PHI.
3 The New Rules for Business Associates
4 The American Recovery and Reinvestment Act of 2009: Stimulus Act Changes to Business Associates Presented By: Michele Madison
5 Polling Question How familiar are you with the new Business Associate Rules under HITECH? Not at all Somewhat informed Very informed
6 Expanded Business Associates Each organization that provides data transmission of Protected Health Information to such entity or its Business Associate and that requires access on a routine basis to such Protected Health Information, such as a Health Information Exchange Organization, Regional Health Information Organization, E-prescribing, Gateway, or each vendor that contracts with a Covered Entity to allow that Covered Entity to offer a personal health record to patients as part of its electronic health record and it is required to enter into a Business Associate Agreement.
7 Increased Application and Enforcement Business Associates are now directly subject to specific requirements Penalties directly apply to Business Associates Increased Penalties Enhanced Enforcement Activities
8 Application of Privacy Provisions and Penalties to BA Additional requirements that relate to privacy and security are now applicable to Business Associate. Include provisions in Business Associate Agreement: Administrative Safeguards Physical Safeguards Technical Safeguards Civil and Criminal Penalties apply to Business Associate.
9 Criminal Penalties Covered Entities should be aware of the additional Penalties and the Enforcement Activities: Enhanced Criminal Penalties Willful neglect standard Additional funding for Enforcement Activities. In 3 years, the individual harmed may receive a % of the CMP collected from the offense.
10 Penalty Tiered Increase Minimal levels of Penalties based on Intent: $100 - $25,000 - Person did not know and would not have known $1,000 - $100,000 - Reasonable cause and not willful neglect $10,000 - $250,000 - Willful neglect $50,000 -$1,500,000 - Willful neglect and not corrected
11 State Attorney General Permits civil actions on behalf of patients. May enjoin the actions; and Obtain damages not to exceed $25,000 annually. Attorneys fees may be recovered by State.
12 Polling Question This Question is for Covered Entities: How much does this information affect which vendors you do business with? Greatly affects it Somewhat affects it Does not affect it at all
14 Security and Notice Requirements Security provisions of HIPAA now apply to a Business Associate of a Covered Entity in the same manner that such sections apply to the Covered Entity. Business associates subject to same penalties as Covered Entities. Also applies to vendors of personal health records. Covered Entities and Business Associates must track and notify individuals when their unprotected information has been put at risk through a security breach by September 16, Policy of empowering the individual with understanding where individual s information accessed in unauthorized manner. Secretary will consult with stakeholders and issue guidance on the most effective and appropriate technical safeguards. Initial guidance to be issued within 60 days after enactment of the HITECH Act (by April 19, 2009). These are to be updated annually.
15 Security and Notice Requirements Applies to any Covered Entity or BA/vendor that: Accesses, maintains, retains, modifies, records, stores, destroys or otherwise holds, uses, or discloses unsecured protected health information. Applies directly to vendors, regardless of whether a business associated agreement is executed.
16 Security and Notice Requirements Obligation to notify triggers upon discovery of a breach: Discovery determined to be the first day on which such breach is known or should reasonably have been known to such entity or associate to have occurred. Knowledge by any person that is an employee, officer or other agent of the entity or associate. Following discovery of a breach of unsecured protected health information, Covered Entity and Business Associate must: Covered Entity must notify the individual. Business Associate must notify the Covered Entity.
17 Security and Notice Requirements Notice to Individual must include: Identification of each individual whose unsecured protected health information has been, or is reasonably believed to have been accessed, acquired, or disclosed during such breach. Brief description of what happened, including the date of the breach and the date of discovery of the breach. Description of the types of unsecured protected health information that were involved. Steps the individual should take to protect themselves from potential harm resulting from the breach. Description of watt the covered entity involved is doing to investigate the breach, to mitigate losses, and to protect against any further breaches. Contact procedures for individuals to ask question or learn additional information.
18 Security and Notice Requirements Notice to the Secretary by Covered Entities: For breaches impacting 500 or more individuals, notify the Secretary immediately. For breaches impacting fewer than 500 individuals, maintain a log and notify the Secretary annually submit such log.
19 Security and Notice Requirements Notice Process Notice Timing: Notice must be made without unreasonable delay and in no case later than 60 calendar days after discovery of a breach. Delay allowed if a law enforcement official determines that a notification, notice or posting would impede a criminal investigation or cause damage to national security. Methods of Notice: Written notification by first class mail to individual. Substitute notice process for insufficient or out of date contact information. Media notice information for 500 individuals or more.
20 Polling Question Have you reviewed the Administrative, Technical, & Physical Safeguards and addressed each rule?
21 Next Steps Covered Entities should evaluate what entities serve to exchange health information or serve as Personal Health Records Covered Entities should evaluate their current business associate agreements and draft revised language Business Associates (new BAs) should evaluate current processes and perform a risk assessment under the Security Regulations Implement HIPAA Security Safeguards
22 Thank You Michele Madison Partner, Healthcare Morris, Manning & Martin, LLP This presentation is provided as a general informational service to clients and friends of Morris, Manning & Martin, LLP. It should not be construed as, and does not constitute, legal advice on any specific matter, nor does this message create an attorney-client relationship. These materials may be considered Attorney Advertising in some states. Please note, prior results discussed in the material do not guarantee similar outcomes.
23 Compliance +, LLC
26 Polling Question Do you have processes and procedures in place to address the handling, reporting, and logging PHI?
27 What do you need? The following list is from an actual BA of one of my clients. It illustrates the length that this BA has gone in order to protect themselves and ultimately their clients patients PHI. There is value in being a trusted BA by implementing the proper protections for your clients patients PHI.
28 Policies & Procedures Policy General HIPAA Compliance Policy Policies and Procedures Policy Documentation Policy Documentation Retention Policy Documentation Availability Policy Documentation Updating Policy HHS HIPAA Investigations Policy Breach Notification Policy Privacy Officer Policy HIPAA State Law Preemption Policy Procedure Developing or Changing Policy or Procedure) Data Destruction Procedure Accountability of Disclosures Procedure Escalating and Handling HHS HIPAA Investigation and other Third Party Requests Security and Privacy Incident Response Plan
29 Policies & Procedures Policy HIPAA Training Policy PHI Uses and Disclosures Policy Patient Rights Policy Privacy Complaints Policy Risk Management Process Policy Risk Analysis Policy Risk Management Implementation Policy Procedure Access Request Escalation and Handling Procedures Complaints Escalation and Handling Procedure Sanction Policy Information Systems Activity Review Policy Assignment of Security Responsibility Policy
30 Policies & Procedures Policy Authorization and Supervision Policy Procedure Access Screening Policy Access Termination Policy Access Authorization Policy Access Establishment and Modification Policy Security Reminders Policy Malware Protection Policy Log In Monitoring Policy Password Management Policy Security Incident Procedures
31 Policies & Procedures Policy Procedure Data Backup Plan Disaster Recovery Plan Emergency Mode Operations Plan Testing & Revision Procedures A&D Criticality Analysis Policy Evaluation Policy Business Associates Policy Contingency Operations Policy Facility Security Plan Access Control & Validation Procedures
32 Policies & Procedures Policy Maintenance Records Policy Procedure Workstation Use Policy Workstation Security Policy Media Disposal Policy Media Re Use Policy Hardware & Media Accountability Policy Data Backup & Storage Policy Unique User ID Policy Emergency Access Procedures Automatic Log Off Policy
33 Policies & Procedures Policy Encryption & Decryption Policy Audit Controls Policy Integrity Controls Policy Person or Entity Authentication Policy Procedure Integrity Controls Procedure Postal Communications Containing PHI Policy
34 Confused? Where to start? Diagram workflows and PHI processing Diagram network Examine for threats, vulnerabilities, risks Document access Document all with P&P Monitor and adjust compliance
35 Notes A covered Entity may request copies of your P&P. A covered entity will require a sign BA Agreement. The new BA agreements make you responsible rather than passing it off to the CE. Protect the PHI!
36 Thank you Paige Joyner Compliance +, LLC
37 BA Perspective The IT Support Provider who Informs & Protects
38 Polling Question If you are a Business Associate do you: Transmit Health Records Store Health Records Have Access to Health Records
39 Why BlueWave Became HIPAA Compliant Realized Responsibility PHI our engineers can access through the network (Access) Patient Data that rest in our Data Center (Store) BlueWave Data Center Hosted Over 100 server in our data center that hold PHI Patient Data backed up by our Disaster Recovery program (Transfer)
40 BlueWave s HIPAA To-Do List Privacy Manuals (All) Security Manuals (Electronic Access) Workforce Training (All) Administrative, Physical & Technical Safeguards (Electronic Access) Vulnerability Test (Electronic Access) Network Diagram (Electronic Access) Network Asset List (Electronic Access) Work Plan (Electronic Access) Business Associate Checklist (Share PHI with Subcontractors) LOCK IT DOWN PROTECT THE PHI
41 Why? 23% of breaches involve a BA 12 of the Largest Breaches involved a BA 8 of the CE s in the largest breaches, modified or terminated their relationship with the BA Reputation Loss All client s get fined if the PHI is not secure Fines for BlueWave Become the Trusted Resource for IT Support BIGGEST REASON Protect the Practices & their patients
42 Facts 330 major healthcare breaches affecting 11.8 million individuals. 23% of those involved BA = over 2.7 million Business Associates are the biggest vulnerability to a CE because they are not prepared If a breach occurs the CE name is listed along with the BA Emergency Healthcare Physicians, Ltd. State: Illinois Business Associate Involved: Millennium Medical Management Resources, Inc. Approx. # of Individuals Affected: 180,111 Date of Breach: 2/27/10 Type of Breach: Theft Location of Breached Information: Portable Electronic Device, Other
43 Lessons From Other BA s KPMG Lost an unencrypted flash drive affecting more than 4,500 patient records. Their client New Jersey Healthcare System. Breach affected 2 facilities: 3,630 patients at Saint Barnabas Medical Center 965 patients at Newark Beth Israel Medical Center Note: 8 months later KMPG was awarded a $9.3 million contract to do 150 random audits on practices and business associates.
44 Lessons From Other BA s Heritage Health Solutions - An unencrypted laptop belonging to VA contractor Heritage Health Solutions was stolen from a vehicle, compromising the records of more than 600 veteran. Heritage Health Solutions has 69 contracts with VA 25 of those don t have clauses requiring personal data to be encrypted Booz Allen The group hired to make a list of all covered entities and business associates has been the target of a hacking group called Anonymous. The information hacked included 90,000 military e- mail addresses and password hashes.
45 Lessons From Other BA s Dentaquest A laptop was stolen out of the trunk of the subcontractors vehicle. The computer was password protected, but did not have any other safeguards to prevent unauthorized access to the information. IBM 9 servers disappeared out of the data center. The data held nearly 2 million records. To make matters worse, the CE, Healthnet, waited 2 months to report it. Archive Data Solutions aka Iron Mountain - South Shore said it shipped the backup files to the then unnamed contractor but was informed months later that only a fraction of the boxes were received.
46 Lessons From Other BA s Computer Program & Systems, Inc. (CPSI) Someone gained unauthorized access into the system. 763 records were compromised. Provides IT support to rural hospitals in Texas and has a host of IT services including: Hosted/Cloud Services Disaster Recovery Collaboration & Connectivity Systems Management Security Services
47 Lessons From Other BA s Rick Lawson, Professional Computer Services (IC) Hacking compromised 2,000 records at his clients site Is now listed as the CIO for Professional Consulting & Technical Services where he states his strengths are: Advanced network monitoring, auditing, security, and intrusion detection and alerting. Custom security solutions for VPN and remote access. HIPAA-compliant medical and dental practice management. Business Continuity planning, disaster prevention and recovery. Virus and malware prevention and removal, plus data recovery services.
48 What Do These Have in Common? All breaches could have been prevented if they had a HIPAA Program in place. All of them positioned themselves as healthcare & HIPAA experts on their website. If you have not verified your BA s HIPAA Compliance these can affect you. Each one of these breaches compromised over 500 PHI records.
49 Feedback from BA s I have called on for my clients 80% told me they were compliant until they got stuck on some questions. Others Said: This is very Invasive It is a huge Expense during hard economic times It is Minor in the realm of government regulations It is Un-enforced/Un-enforceable Not applicable to me
50 Must Educate BA s They were never informed by the government that they had to do this. Most will get defensive/argumentative must have tough skin. You must educate them on the HITECH law & HIPAA rules. You must be up-to-date on the legislative changes affecting healthcare. Must understand that this is an expense to them they will probably not change unless they have multiple clients demanding this.
51 Who are Your BA s? Anyone who stores, transmits or accesses PHI on your network.
52 HIPAA is Not an Annual Check-off Unlike some regulatory compliance programs, HIPAA is not just a one time or annual check off list. Business Associates have to change the way they do business on a daily basis.
53 Example of What BlueWave Has Done Regarding IT Support: Web Portal with Pictures of Engineering Team Password Vault Workforce Training Workforce Clearance Termination Procedures ACCESS to PHI
54 Regarding Cloud Computing Finger Print Scanning Iris Scanning 2 layers of Security Personnel Encryption at Firewall Level Only 3 engineers with physical access to the cage Password Vault Example of What BlueWave Has Done VPN Tunnel Backed up to Phoenix Data Center Stored PHI
55 Example of What BlueWave Has Done Regarding Disaster Recovery Use Same Data Facilities Backed up to Encrypted Server Backed up online to secure data centers in Atlanta & Phoenix Bi-Annual Testing Option Server & Desktop DR Capabilities PHI in Transit
56 Example of What BlueWave Has Done Consistent Access Logging: Client can pull reports on: Date Accessed Who Accessed Type of Issue What was done Clients can pull these reports from this month to up to the entire length of their contract Network Diagram Asset Inventory LOGGING REPORTS
57 A Business Associate Agreement is Not Enough MUST VERIFY Get a copy of their Policies and Procedures Ask specific questions on how they are going to service your account Find out if they store their information elsewhere and if they have had that audited Ask specific safeguard questions Ask about any subcontractors that have access to your practices PHI
58 Be Wary of BA s Who: Fight you on this Want to do the minimum necessary to get compliant You Need a BA Who You Can: Trust they will protect your patients PHI. Trust they are knowledgeable enough to know how to protect the PHI. Trust they are serious about protecting PHI. Trust they are going to maintain the PHI. Is willing to prove all the above.
59 Example of What BlueWave Has Done Packaged the Compliance Program we performed internally to help protect Covered Entities & their Business Associates. Became part of the solution rather than an obstacle.
60 Form a Team to Protect PHI As you call your BA s, you are going to find a lot of kickback. Other practice managers are going through the same thing. For this reason it is important to: Keep a list of those who are compliant. Share that list with other practice managers. Share the list with BlueWave. Next year we will post it on our website.
61 Polling Questions BlueWave is putting together a formal list of Business Associates who meet the compliance requirements. If you would like to be informed of who met the qualifications, please check yes here. If you would like to add your own business associates who meet the criteria to the list, please check yes here.
62 Thank you Deborah Frazier Bluewave Computing
63 Privacy, Security & Disaster Recovery Committee About the Healthcare Solutions Resource Forum (HSRF) Created by Dr. Paige Joyner of Compliance + and Debora Frazier of BlueWave Computing, the Healthcare Solutions Resource Forum (HSRF) is a flagship program designed to bring together prominent thinkers from various disciplines with healthcare executives in order to identify the impact of legislative changes in the areas of technology, operations and finance. The concept of the HSRF was born out of the realization that the healthcare industry is under more pressure than ever before to meet legislative changes, yet the information is so scattered and unclear. By combining the knowledge of experts in various disciplines, members can assimilate information to form clear solutions and address legislative changes. Together we believe we can have a positive impact on the healthcare community, whereas on our own we can only impact our small part of the world.
64 Polling Question The Healthcare Solutions Resource Forum will be sending out a survey to all of those who registered for this function. Upon returning the survey you will be entered into a drawing for a $100 AMEX gift certificate. The purpose of the survey is to find out what other topics you might be interested in. In addition, you will have an opportunity to request a 15 minute consultation with any of the speakers on this call. The winner will be announced to all participants at the end of the business day. If you would like to be entered into the drawing, please check if you would like to be contacted by or phone.
65 For More Information on the Healthcare Solutions Resource Forum